BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16774946 · Received April 20, 2023

    Report

    Report Number
    9610877-2023-00115
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 4, 2023
    Report Date
    June 28, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: SERIAL NUMBER IS UNKNOWN. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: BASED ON THE INVESTIGATION DATA. THE POTENTIAL/FUNDAMENTAL CAUSE OF THE FAILURE IS THAT THERE IS NO FAILURE IN THE ENDOSCOPE. IT IS DIFFICULT TO CONTROL THE TREATMENT DEVICE. AND THE PROCEDURE TO ACCESS THE PANCREATIC BILE DUCT MAY CAUSE STONES TO ACCUMULATE ON THE ELEVATOR. IT WAS DETERMINED, THAT THE INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING THE RAISING TABLE NOT BEING ABLE TO BE LOWERED. PENTAX MEDICAL HAS NOT RECEIVED, ANY FURTHER INFORMATION FOR THIS EVENT. AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    SINCE PURCHASING TWO NEW DUODENOSCOPES (ED34-I10T2), THE USER HAS COMPLAINED ABOUT DIFFICULT HANDLING DURING ERCP AND DURING VIDEO CHOLANGIOSCOPY WITH THE SPYGLASS DISPOSABLE CHOLANGIOSCOPE FROM BOSTONSCIENTIFIC. CUSTOMER PREVIOUSLY HAD THE FIXED ALBARRAN LEVER RATHER THAN THE DEC VERSION. INSTRUMENTS SUCH AS BALLOONS AND ALSO THE SPYGLASS CAN BE CONTROLLED AND PUSHED VERY POORLY BY THE ALBARRAN LEVER, RESULTING IN "KINKING" AND DAMAGE TO THE BALLOONS USED (COMPANY MTW). ACCORDING TO THE CUSTOMER, WHEN TESTING THE CLOSED LEVER (EX-VIVO), A SHARP EDGE OF THE ALBARRAN LEVER CAN BE OBSERVED. ALSO, DURING THE EXAMINATION, SMALL STONES OFTEN COLLECT UNDER THE ALBARRAN LEVER, SO THAT IT IS DIFFICULT/HARDLY POSSIBLE TO OPEN IT AGAIN. REGARDING THE VIDEO CHOLANGIOSCOPE, THE USER HAS ASKED A REPRESENTATIVE OF BOSTON SCIENTIFIC TO COME TO THE HOUSE FOR AN ASSESSMENT OF THE CHOLANGIOSCOPES USED- TO BE DONE IN THE COMING DAYS. CUSTOMER HAS KEPT ONE USED DEC CAP AND TWO USED CHOLANGIOSCOPES. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559758 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown